What is medical device certification and why is it important for my business?

In the EU, medical device certification is a CE mark, indicating that the product meets EU safety, health, and environmental protection requirements. In the US, it means approval by the FDA, ranging from registration for Class I devices to 510(k) clearance for Class II devices or PMA for Class III devices.

What is the certification process for medical devices?

The certification process involves determining product risk class, establishing a Quality Management System (QMS), creating technical documentation, undergoing an audit (if required), and maintaining post-market requirements.

What are the regulatory requirements for certification and does FormlyAI cover them for my device?

Formly covers all standards required to meet US and EU market requirements, including EU MDR 2017/745, US FDA 21 CFR, ISO 13485, ISO 14971, IEC 62366, and IEC 62304.

I don't know anything about medical device regulations. Is Formly right for me?

Yes! Formly's software is built for everyone, including those unfamiliar with medical device regulations. The Document Autopilot generates MDR and FDA compliant documents, and built-in descriptions and video walk-throughs guide you through the rest.

When should I start to work on certification? Can I start too early on this?

You can’t be too early but you can be late. Once you understand what product you want to build, you can start your certification journey.

Can my product be Class I now and then be Class IIA (or Class II) later?

Yes. See more in our blog post on the subject.

How long does it take to get my medical device certification?

This depends on the medical device class. Class I software medical devices can take days to months, Class II (IIa / IIb) medical devices can take months to years, and Class III devices take multiple years.

Formly: AI-powered software for medical device certification and compliance in the EU and US.

Name: Formly
Rating: 5 (76 reviews)
Author: toolify

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AI-powered software for medical device certification and compliance in the EU and US.

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Nov 16 2024

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Formly Product Information

What is Formly?

Formly is an AI-powered software designed to simplify and expedite the medical device certification process, particularly for startups. It offers tools for creating and managing required documentation, expert regulatory guidance, and AI-backed documentation writing to help companies achieve EU and US medical device compliance and get to market quickly and on budget. Formly supports various standards including MDR 2017/745, US FDA 21 CFR, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.

How to use Formly?

Use Formly to create and manage medical device documentation, access expert regulatory guidance, and leverage AI to automate documentation writing. The platform guides users through the certification process, from determining product risk class to maintaining post-market surveillance.

Formly's Core Features

AI-powered documentation generation

Expert regulatory guidance

Quality Management System (QMS) creation

Technical documentation building

Compliance alerts and automatic updates

Document approval and revision management (eQMS)

Formly's Use Cases

Achieving EU CE mark certification for medical devices

Obtaining US FDA approval/clearance for medical devices

Creating and maintaining ISO 13485 compliant QMS

Building audit-proof technical documentation

Managing document approval and revisions

FAQ from Formly

What is medical device certification and why is it important for my business?
What is the certification process for medical devices?
What are the regulatory requirements for certification and does FormlyAI cover them for my device?
I don't know anything about medical device regulations. Is Formly right for me?
When should I start to work on certification? Can I start too early on this?
Can my product be Class I now and then be Class IIA (or Class II) later?
How long does it take to get my medical device certification?